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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 90 T-NHL (ACT-1)


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO90 news

Both amendment 1 & 2 have been approved for the HO90 T-NHL (ACT1) study.

After receipt of the protocol signature pages, adjusted ICF and signed checklist at the HOVON Data Center, patients can be included again.

 

The HO90 T-NHL study has been initial approved by the METC of the UMC Groningen on 25-NOV-2008.

This study is a so-called intergroup study in which HOVON participates. Leading group is the Nordic Lymphoma Group (Prof F. d'Amore)

 

If you wish to participate in this study please contact the HOVON Data Center (M. Luten), before taking any action.

 

Please notice that a FAQ document is available for this study. If you have any other question regarding this study, do not hesitate to contact the HOVON Data Center.


1. Overview



Summary

A randomized phase III study to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP versus 2-weekly CHOP alone and consolidated by autologous stem cell transplant, in young patients with previously untreated systemic peripheral T-cell lymphomas


Status

closed


Members

Leading group: Nordic Lymphoma Group



Study details



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Study specific


Target number of patients

308


Approved by

METC UMC Groningen: 25-NOV-2008


Change history / amendement

Amendment 1 approved on 20-NOV-2009
Amendment 2 approved on 20-NOV-2009


Study objectives

Determination of the efficacy and safety of the monoclonal antibody MabCampath® (Alemtuzumab) combined with two-weekly CHOP supported by G-CSF


2. Patient eligibility criteria



Inclusion criteria

Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (>= 7.5 cm) and stages II to IV.
Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C):
 Peripheral T-cell lymphoma, unspecified (PTCL NOS)
 Angioimmunoblastic T-cell lymphoma
 Enteropathy-type T-cell lymphoma
 Subcutaneous panniculitis-like T-NHL
 Hepatosplenic T-cell lymphoma
 Extranodal NK/T cell lymphoma, nasal type
Age 18-60 years at the time of randomization
Life expectancy of 3 months or longer
ECOG performance status 0, 1 or 2 at randomization (see appendix D). PS 3 acceptable if lymphoma-related.
Measurable disease
Written informed consent


Exclusion criteria

Patients with NK/T-NHL of the following type:
 Precursor T cell lymphoblastic lymphoma/ leukemia
 All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL, HTVL1-pos ATL)
 Alk-positive and negative anaplastic large cell lymphoma
 Blastic NK cell lymphoma
 Cutaneous T-cell lymphoma, transformed or not
Concurrent severe and/or uncontrolled medical disease (e.g.uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.
Known hypersensitivity to murine or chimeric antibodies or proteins
Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45 %
Significant renal dysfunction (serum creatinin >2 times upper limit of normal), unless related to NHL
Significant hepatic dysfunction (total bilirubin > 2 times ULN or transaminases >= 2.5 times ULN), unless related to NHL
Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmonary function test shows FEV1<50% or a diffusion capacity <50% of the reference values
Suspected or documented central nervous system involvement by NHL
Patients known to be HIV-positive
Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg
Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal type
History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
Unwillingness or inability to comply with the protocol
Simultaneous participation in any other study protocol
Pregnant and nursing women


3. Registration (& randomization) of patients



Registration

Central registration at the Trial Office Aarhus:
Helle Erbs Tolbod / Malene Moller Staal
Fax number.....: +45-8949/7597


Registration criteria

The following information will be requested:



The patient should be registered and randomized immediately after satisfactory completion of
screening tests and obtaining informed consent, and before the start of chemotherapy. Patients
need to be registered at the Clinical Trial Office (Aarhus University Hospital, Denmark).

The following information will be requested at randomization:
1. Protocol number
2. Institution name
3. Name of caller/responsible investigator
4. Patient’s initials or code
5. Patient’s hospital record number
6. Sex
7. Date of birth
8. Date of diagnosis of NHL
9. WHO classification
10. Pathology result from referral/reference pathologist
11. Eligibility criteria (i.e. all inclusion and exclusion criteria)

All eligibility criteria will be checked with a checklist.
Each patient will be given a unique patient study number. Patient study number will be given
immediately by phone and confirmed by fax or email.
Patients will be randomly allocated to one of
the two therapy arms at a ratio 1:1 by means of a minimization algorithm with the following
stratifying factors:

a) Centre
b) Value for serum LDH (LDH  Upper Normal Value versus LDH > Upper Normal Value)
c) General status of patient (ECOG performance status 0 and 1 versus >1)
d) Stage I and II versus III and IV
e) Number of extranodal involvements (0-1 vs >1)
f) Bulky disease (no vs yes)
g) Histology (other vs NK/T cell nasal type)

The treatment allocation of a new patient is based on data for these factors for all previous patients
and thus takes use of the central study data base. The technique secures that the patients will be
balanced between therapy arms for the stratifying factors.


4. Participating parties



Principal investigator

Prof F. d'Amore (Nordic Lymphoma Group)


Coordinating investigator(s)

For the Netherlands: Prof J.C. Kluin-Nelemans


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

S. Cunha (s.cunha@erasmusmc.nl)


Central data management

IMISE, University of Leipzig
(CRFs and query answers should be sent to the Clinical Trial Office, Aarhus University Hospital, Denmark. They will forward CRFs and query answers to IMISE)


Other functions

Central review pathologist:
Dr. Arjan Diepstra
UMCG
Department of Pathology
P.O. Box 30001
NL – 9700 RB Groningen

e-mail: a.diepstra@path.umcg.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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